CTIS2023-506866-30-00进行中（未招募）1 期
An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an anti-human epidermal growth factor receptor 2 (anti-HER2) antibody-drug conjugate (ADC), in Previously Treated Subjects with HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer - BB-1701-G000-205
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject must be willing and able to comply with all aspects of the protocol and as such provide written informed consent prior to any study-specific screening procedures., Life expectancy of at least 3 months., Adequate organ function and laboratory parameters., Male or female, aged =18 years at the time of informed consent., Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry [IHC] status of 3+, or a positive in situ hybridization [ISH] test [fluorescence, chromogenic, or silver-enhanced ISH] if IHC status is 2+) or HER2- low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to T-DXd treatment., Must have previously received T-DXd., Sufficient tumor tissue is required for HER2 status testing at a central laboratory., Measurable disease meeting the following criteria as assessed by the investigator:according to RECIST 1.1. NOTE: Subjects with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion., Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimens in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo)adjuvant chemotherapy, this would count as 1 line of chemotherapy., If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to further benefit from it., Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
排除标准
- •Presence of brain or subdural metastases, unless subject has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 2 weeks prior to starting treatment in this study., Concomitant active infection requiring systemic treatment, except: - If known to be human immunodeficiency virus (HIV)-positive, must be on anti-HIV therapy for at least 4 weeks and have a CD4+ T-cell (CD4+) count =350 cells/µL and an HIV viral load less than 400 copies/mL - If meets the criteria for anti-hepatitis B virus (HBV) therapy, must agree to take anti-HBV therapy, if known to be HBV-positive as defined by positive hepatitis B surface antigen or hepatitis B core antibody. HBV viral load must be undetectable. - If known to be hepatitis C virus (HCV)-positive must have completed curative therapy for HCV. HCV viral load must be undetectable., Known history of active bacillus tuberculosis (TB)., Any medical or other condition which, in the opinion of the investigator, would preclude the subject’s participation in the clinical study., Diagnosed with meningeal carcinomatosis., Received anticancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, etc) or an investigational drug or device within the past 28 days or 5 half-lives, whichever is shorter., Prior treatment with eribulin., Any prior allergic reactions of Grade =3 to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid)., Residual toxic effects of prior therapies or surgical procedures that is Grade =2 (except alopecia or anemia)., Grade =2 peripheral neuropathy or history of Grade =3 peripheral neuropathy or discontinued any prior treatment due to peripheral neuropathy., Active pneumonitis/interstitial lung disease (ILD) or any clinically significant lung disease (eg, chronic obstructive pulmonary disease), history of Grade =2 pneumonitis/ILD, or received radiotherapy to lung fields within 12 months of Cycle 1 Day 1 of study treatment., Any of the following cardiac conditions: - Congestive heart failure greater than New York Heart Association Class II or left ventricular ejection fraction (LVEF) <50% measured by multigated acquisition (MUGA) scan or echocardiogram. - Has a corrected QT interval prolongation per Fridericia formula (QTcF) >470 ms (for both males and females) based on screening triplicate 12-lead ECG.
研究者
相似试验
招募中
2 期
A clinical trial to study the Dose, Safety and tolerance of TK-112690 injection in Head and Neck cancer patients receiving radiation and chemotherapyCTRI/2023/11/060212Tosk Inc
进行中（未招募）
1 期
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)MedDRA version: 21.1Level: PTClassification code: 10062194Term: Metastasis Class: 100000004864CancerCTIS2023-508422-95-00Synthorx Inc.294
招募中
1 期
A study to investigate the safety and efficacy of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatmentsMultiple MyelomaJPRN-jRCT2051230065Ishibashi Hideyasu124
进行中（未招募）
1 期
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple Myeloma (RRMM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2019-004793-26-DEHarpoon Therapeutics, Inc.114
尚未招募
1 期
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose ExpansionStudy of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patientswith Relapsed/Refractory Multiple MyelomaMultyple Myeloma C90.0C90.0Multiple myelomaDRKS00023656Harpoon Therapeutics, Inc.70